USP Specialist (m/w/d).

Job ID: 10905

Jetzt bewerben
Discipline
Quality/Production
Type of employment
Festanstellung
Company

Our Client is a biopharma company with state-of-the-art facilities. Operating across international centers specialized in clinical manufacturing and commercial scale production. Our client provides expertise and facilities from cell line development over process development, API production to fill & finish for partners and in-house biological pipeline. The leading one stop shop for biologics from cell line development to drug product.

Responsibilities

General:

Ensuring stable operation of the Mammalian Cells Culture Team and performance of production and validation tasks entrusted to it. Participation in technology transfer in accordance with cGMP regulations and internal during the implementation of projects related to the introduction of new biotechnology products. Manufacture of biotechnology products in accordance with GMP principles and FDA requirements to obtain a product of specified quality in the specification.

In detail:

  • Coordinating and managing a Team of Specialists within the framework of tasks imposed on the Mammalian Cells Culture Team

  • Planning and assigning tasks to subordinates, controlling and monitoring the status of performed activities

  • Participation and monitoring of technology transfer processes and commercial production in accordance with the principles of cGMP and internal regulations, reporting of activities performed, as well as problems and proposals for changes to the direct supervisor

  • Planning and enforcement of production activities in accordance with the Good Manufacturing Practice

  • Ensure that all activities undertaken by the Team are in accordance with the requirements of cGMP, FDA, EMA, ICH

  • Problem solving, explanation of deviations, implementation of changes in accordance with GMP and internal regulations

  • Supporting qualifying activities, supervision of qualification documentation in accordance with GMP and internal regulations

  • Support for the Team's current tasks as far as it is necessary

  • Supervision of the GMP production area as well as process and system documentation, ensuring an appropriate status enabling continuous work in accordance with the requirements of cGMP

  • Preparation and review of process documentation in accordance with GMP rules

  • Close cooperating with the Quality Department
Requirements
  • Academic degree in science (biotechnology, biochemisty, process engineering)

  • More than 3 yrs working in the field of cell culture USP

  • Fluent English language
Benefits
  • An opportunity to build and shape an organization according to your ideas

  • Internationally competitive compensation & benefits
Region
Europa